Portable measuring system having an optimized assembly space

ABSTRACT

A portable measuring system which analyzes a liquid sample for at least one analyte. The portable measuring system has a substantially moisture-proof housing with an internal atmosphere. The housing prevents moisture from the air and water vapor from penetrating into the housing. The portable measuring system also has at least one test element support inserted into the internal atmosphere of the housing. The test element support is equipped with a retaining structure and a test element that is supported by the retaining structure. The test element support is designed such that, after insertion into the internal atmosphere, the test element is exposed to the internal atmosphere. A release mechanism is also provided which can convey at least one test element into an application position within the internal atmosphere of the housing. In this application position, the liquid sample can be applied to the test element.

This application is a continuation application of InternationalApplication PCT/EP2007/057023, filed Jul. 10, 2007, which claimspriority to EP 06117422.3, filed Jul. 18, 2006, which are herebyincorporated by reference in their entirety.

BACKGROUND

The invention relates to a portable measuring system with a smallassembly space that can be used to analyze a liquid sample for at leastone analyte contained therein. Measuring systems of this kind are usedin particular in the field of medicine, for example, for blood glucosemonitoring, or in the field of chemical or biological analysis, forexample, environmental analysis.

Monitoring of blood glucose concentration is an essential part of thedaily routine of diabetics. Blood glucose concentration must bedetermined quickly and reliably several times a day in order, ifappropriate, to be able to take suitable medical measures. So as not torestrict the diabetic's daily routine any more than is necessary,suitable portable devices are often employed which are intended to beeasy to carry and to operate such that the blood glucose concentrationcan be measured, for example, at the workplace or even during leisuretime.

Various portable devices are presently available on the market, some ofthem functioning according to different measurement methods. Variousdiagnostic methods are used in these devices, for example, optical oreven electrochemical measurement methods. An example of a frequentlyemployed measurement method utilizes a special kind of electrochemicaltest strips. These test strips are, for example, configured such that apredetermined quantity of blood is conveyed to an electrode system via acapillary system on the test strip. For modern test strips, a quantityof blood of ca. 1.5 ml is sufficient, sometimes even quantities of bloodof less than 1 ml can be used. The electrode system may, for example,involve gold electrodes that are provided with a coating. The coating inmost cases contains different enzymes and so-called mediators and hasthe effect that charge carriers (for example in the form of redoxmolecules) form within the sample on the electrodes, the concentrationof these charge carriers being dependent on the blood glucoseconcentration. The concentration of these charge carriers can bedetermined by means of the gold electrodes and a suitable measurementsystem, for example, by means of a current-voltage measurement, and fromthis concentration it is possible, finally, to calculate the bloodglucose concentration. An example of electrochemical test strips of thiskind is set out in U.S. Pat. No. 5,286,362.

As an alternative to the electrochemical measurement method describedabove, other measurement principles can also be used. Thus, for example,Publication No. WO 01/48461 describes a test strip with light guides forexamining a sample, in particular, of a body fluid, in which a reagentsystem, upon reaction with the sample, leads to a characteristic andoptically measurable change in a detection zone. By way of light guidesthat are let into the test strip, this change can be evaluated by anevaluation device.

The test strips thus form an important element of portable diagnosticsystems. Typically, about 5 to 7 of such test strips are needed each dayby a diabetic. It is essential that the test strips are stored in aclean and dry condition to ensure that the measurement of the bloodglucose concentration is not rendered inaccurate by contamination or bythe effect of moisture.

For this purpose, the test strips are usually stored in suitablecontainers in order to then be removed by the user from the test stripcontainer for a measurement and fitted into a corresponding measuringdevice. Such measuring devices, for example, measuring devices forelectrochemical or optical determination of the blood glucoseconcentration, are known to persons skilled in the art and described,for example, in US Patent Publication No. 2002/0170823 A1.

For storing and dispensing the test strips, magazine systems are alsoknown. For example, US Patent Publication No. 2003/0116583 A1, EP 0 640393 and U.S. Pat. No. 4,911,344 describe suitable storage systems inwhich several test strips are stored in a magazine. EP 1 488 736 alsodescribes a system which contains, instead of individual test strips, atape cassette composed of a long individual test strip with a pluralityof test fields.

In addition to systems in which the test strip magazine and measuringdevice are used as separate units, integrated systems also exist whichnot only comprise several test strips stored in one magazine, but alsoafford the possibility of evaluation of these test strips. Examples ofsystems of this kind are to be found in U.S. Pat. No. 5,489,414, U.S.Pat. No. 6,093,156, and Publication Nos. WO 02/18940, WO 02/055008 or WO03/083469. Some of these systems, for example the system described inU.S. Pat. No. 6,093,156 or Publication No. WO 03/083469, alreadycomprise an integrated lancet system too, which makes it possible toperforate the skin to generate a blood droplet and then permits analysisof the blood droplet using one and the same measuring system.

However, in the systems known from the prior art, the problemsurrounding moisture sensitivity, of the test strips has only beenpartially solved. Thus, for example, German Patent No. DE 103 32 488 andUS Patent Publication No. 2005/0033196 each disclose test systems withintegrated lancet system and test strips, in which blood droplets areapplied directly to test strips. In these cases, however, the teststrips are largely unprotected and thus exposed to the air moisture.

Air moisture, especially at elevated temperatures and over long periodsof time, can affect the sensitivity of the test strips and thus renderthe measurement inaccurate. To avoid this, the systems disclosed inPublication Nos. WO 03/083469 or WO 02/055008, for example, containsseparate, exchangeable, airtight test strip magazines, which areinserted into the actual measuring device. However, this requires dualpackaging of the test strips, which requires considerable assemblyspace, since the test strips are now surrounded by the actual magazinewall as primary packaging and in addition by the wall of the measuringdevice. Analogously, Publication No. WO 2006/047135 also describes acomplex test strip dispenser with a test strip “cartridge.” Here, adevice housing encloses a magazine (cartridge), which for its part hasan outer envelope and an inner envelope. The test strips are stored in amoisture-proof manner in the magazine. Since optimization of size is acrucial factor for portable medical measuring devices, the disadvantageof the dual packaging of the systems known from the prior art is in somecases critically important when it comes to the patient's acceptance ofthe measuring device.

Other systems, for example, the system disclosed in U.S. Pat. No.5,489,414, are based on individually sealed test elements. These testelements can be designed, for example, as multi-use test elements withindividually sealed test areas. A disadvantage of these, however, isthat the seal of the test elements has to be removed before use, whichrequires additional mechanical action, for example, or manual action onthe part of the patient. Automatic removal of the seal, for example byperforation of the seal, requires additional mechanical elements anddrive elements inside the measuring device, which in turn greatlyincreases the assembly space and/or the energy requirement of thesystems.

These examples show that it has not hitherto been possible to entirelysolve the problems of, on the one hand, ensuring that disposable testelements for reloading of the measuring devices can be transported tothe measuring device in an airtight package or seal (for examplecommercially) and, on the other hand, of ensuring that these sealed testelements can then be used in the measuring device itself with removal ofthe seal.

SUMMARY OF THE INVENTION

Embodiments according to the present invention provide a portablemeasuring system for analysis of a liquid sample, in particular, for usein medicine, which system has a small assembly space and yet permitssubstantially airtight storage of test elements in the measuring device.

A portable measuring system is disclosed which is used to analyze aliquid sample for at least one analyte contained therein. The portablemeasuring system can, in particular, be a system for glucosemeasurement, in particular, blood glucose measurement, and/or forcholesterol measurement and/or coagulation measurement. Alternatively,or in addition, however, other analytes can also be determined, forexample, for their concentration or presence, or corresponding otheranalyses can be performed, for example, pH measurements or similarchemical analyses. It is also possible, for example, to performimmunology measurements or similar measurements using the test device.The sample will in particular be a liquid sample, for example, blood,urine, saliva or stools. However, other kinds of samples are alsoconceivable, for example gaseous samples.

The analysis is based on the use of test elements, for example, opticaland/or electrochemical test elements, as are known from the prior art.For example, these test elements can be in the form of test strips.

The portable measuring system comprises a measuring device that has amoisture-proof housing with an internal atmosphere. The moisture-proofhousing prevents air moisture and/or water vapor (collectively referredto as “moisture”) from penetrating into the internal atmosphere of thehousing when the moisture-proof housing is in its closed state. This canbe achieved, for example, by suitable sealing elements and/or productionmethods known from the prior art.

The portable measuring system also has at least one test element supportwhich can be inserted into the internal atmosphere of the housing andwhich has at least one retaining structure and at least one test elementthat is supported by the at least one retaining structure and that isused to analyze the liquid sample. The at least one test element supportis designed in such a way that, after insertion of the test elementsupport into the internal atmosphere of the housing, the at least onetest element is exposed to said internal atmosphere.

To this extent, the proposed system has similarities to the magazinesystem disclosed in U.S. Pat. No. 6,908,008, for example. In contrast tothe system known from U.S. Pat. No. 6,908,008, in which a test strip hasto be dispensed from the airtight magazine for application of the liquidsample, an underlying concept of embodiments taught herein is that theliquid sample can be applied to a test element to be used within theinternal atmosphere of the housing itself.

For this purpose, the disclosed portable measuring system can have arelease mechanism designed to convey at least one test element into anapplication position within the internal atmosphere of the housing. Theliquid sample can be applied to the at least one test element in theapplication position.

The disclosed portable measuring system therefore does not need anairtight primary packaging around the test elements, which packagingwould have to be removed prior to application of the liquid sample, orfrom which packaging the test elements would have to be withdrawn priorto application of the liquid sample. In this way, the assembly space ofthe portable measuring system can be considerably reduced.

The at least one test element support can be sold and stored in aremovable package, for example, in what is referred to as a “blisterpack.” In this package, the test elements are protected against moisturefrom ambient air and other atmospheric influences. To use them, thepatient opens the package and inserts the test element support into theinternal atmosphere of the housing, for which purpose the moisture-proofhousing can be flipped open, pushed open or unscrewed, for example. Onlyduring this brief insertion time are the test elements exposed to theambient air. Then, after the housing has been closed, the test elementsare stored directly in the internal atmosphere of the housing withoutany additional sealing. The outward seal is now effected by themeasuring device itself. For this purpose, all or part of the housing ofthe measuring device is designed to be moisture-proof, in such a waythat the internal atmosphere of the housing is protected.

In addition, a desiccant can be received in the internal atmosphere ofthe housing. Alternatively, or in addition, a desiccant can also beconnected to the at least one test element support, such that a new,unused desiccant is inserted into the internal atmosphere of the housingeach time a test element support is replaced. The amount of desiccant ispreferably to be chosen such that the desiccant is able to bind themoisture that penetrates through the housing walls by diffusion and bypassing through microscopic leaks during the desired storage period, andpreferably, in addition, the moisture that is introduced when applyingthe sample into the internal atmosphere of the housing.

The possibility of air moisture penetrating into the internal atmosphereof the housing exists only for the brief time in which the liquid sampleis being applied to the at least one test element to be used. Forapplication of the liquid sample, the housing has an applicationopening. This application opening is equipped with at least one sealingelement. This at least one sealing element can have a sealing lip, asealing slide, an application flap, a movable sealing element and/or atwo-component plastic structure with at least one rigid and at least oneflexible housing component. This application opening and the at leastone sealing element connected thereto are in principle required onlyonce per measurement system, such that assembly space can be cut downand no complicated sealing constructions for several openings areneeded.

The liquid sample can be applied, for example, by a procedure in which apatient, for example, using a lancet system, generates a blood dropleton the skin surface, for example, of a finger pad, and then opens theapplication opening by pressing or sliding it with the finger pad orwith another finger. In this way, the blood droplet can then be appliedto the at least one test element within the internal atmosphere of thehousing.

After the measurement, the sample on the test element is dried by thedry environment within the internal atmosphere of the housing. For thispurpose, it is possible (see above) to provide a suitable excess ofdesiccant. For example, in order to dry a liquid sample, an amount ofapproximately 10 mg of a desiccant with a capacity of approximately 10%by weight is usually required for every 1 microliter of sample volume.

To improve the sealing function of the at least one sealing element, apressure-equalizing structure can also be provided in the portablemeasuring system. This pressure-equalizing structure preventspenetration of water vapor and/or moisture when a pressure of theinternal atmosphere of the housing changes relative to the air pressureoutside the internal atmosphere of the housing. Such pressurefluctuations occur, for example, upon cooling or heating of the portablemeasuring system, which processes are associated with a change in thevolume of the air in the internal atmosphere of the housing and thuswith a pressure fluctuation. This pressure-equalizing structure can, forexample, comprise a flexible volume-modifying element, in particular apressure-equalizing membrane. Other possibilities are also conceivable.

To monitor the internal atmosphere of the housing, a moisture sensorand/or a temperature sensor can also be provided. The moisture sensormeasures the moisture in the internal atmosphere of the housing, and thetemperature sensor measures the temperature. In this way, for example, awarning system can emit a warning to a user if the moisture in theinternal atmosphere of the housing and/or the temperature of theinternal atmosphere of the housing exceeds a predefined threshold value(or in each case one or more threshold values). Other types ofmeasurements are also conceivable, for example, monitoring a “totaldose” (for example, a time integral of the moisture and temperature) towhich the test elements have thus far been subjected in the internalatmosphere of the housing such that, for example when they have beensubjected to a maximum extent, a warning can be generated to tell theuser that new test elements ought to be used. It is thus possible, forexample, to monitor a “climate integrator”, which represents a timeintegral over temperature and moisture, for example, and accordingly togenerate a warning when a threshold value is exceeded.

The at least one retaining structure can be designed in various ways.For example, it can be a drum with peripheral receiving slits forstrip-shaped test elements. This drum can be a simple injection-moldedpart, for example. Test element tapes with a plurality of measurementareas can also be used, in which case, for example, an unwindingmechanism can be provided. Moreover, the at least one retainingstructure can have, for example, at least one retaining rotor that isable to rotate in the moisture-proof housing.

The portable measuring system can also have an electronic evaluationdevice for determining the presence and/or concentration of the at leastone analyte. This electronic evaluation device is in this casepreferably adapted to the nature and function of the at least one testelement. Thus, for example, an evaluation device can be provided forelectrochemical measurements by means of electrochemical test elements.Alternatively, or in addition, an optical evaluation is alsoconceivable.

The at least one test element may have at least one reagent layer, whichis designed to change at least one property, in particular, an opticaland/or electrochemical property, upon contact with the at least oneanalyte to be detected. With the test element support inserted into theinternal atmosphere of the housing, the at least one reagent layer ofeach test element is preferably exposed directly to the internalatmosphere of the housing. “Directly” can also be understood as meaninga connection of the reagent layer to the internal atmosphere of thehousing via a capillary. In contrast to the prior art, for example, U.S.Pat. No. 5,489,414, individual sealing of the test elements is notrequired.

The portable measuring system as such maybe provided with at least oneintegrated lancet system for perforating an area of skin. Thisintegrated lancet system can be preferably received in themoisture-proof housing. It is thus possible to first carry out aperforation procedure via the application opening and immediatelythereafter, i.e., without changing the position of the area of skin tobe perforated, to generate a blood droplet, with subsequent directapplication of this blood droplet to a test element. This minimizes thenumber of times the housing is opened and during which moisture fromambient air could penetrate into the internal atmosphere of the housing.Moreover, as discussed above, only a single application opening isneeded in principle. In this way, the assembly space of the proposedportable measuring system can be made very small. Such a constructioncan be achieved only with difficulty when using the magazine solutionsknown from the prior art or the systems in which the test elements aresealed individually. The integrated lancet system can have a pluralityof disposable lancets, for example, such that a fresh, unused lancet canbe used for each perforation.

Further details and features of the invention will become clear from thefollowing description of illustrative embodiments. The respectivefeatures can be embodied either singly or in several combinations withone another, though the invention is not limited to the illustrativeembodiments.

BRIEF DESCRIPTION OF DRAWINGS

The above-mentioned aspects of the present invention and the manner ofobtaining them will become more apparent and the invention itself willbe better understood by reference to the following description of theembodiments of the invention, taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 shows a portable measuring system corresponding to the prior art,with dual enclosure of test elements;

FIG. 2 shows a portable measuring system according to the presentinvention without primary packaging of the test elements;

FIG. 3 shows a fully integrated portable measuring system according tothe present invention in a sectional plan view; and

FIG. 4 shows the portable measuring system according to the inventionfrom FIG. 3 in a sectional side view.

The illustrative embodiments are shown schematically in the figures.Identical reference numbers in the individual figures designate elementswhich are identical or whose functions are identical, or whichcorrespond to one another in terms of their function.

DETAILED DESCRIPTION

The embodiments of the present invention described below are notintended to be exhaustive or to limit the invention to the precise formsdisclosed in the following detailed description. Rather, the embodimentsare chosen and described so that others skilled in the art mayappreciate and understand the principles and practices of the presentinvention.

FIG. 1 is a schematic representation of a portable measuring system 110corresponding to, for example, the system disclosed in U.S. Pat. No.6,908,008. In this case, the portable measuring system 110 is designedas a simple storing and dispensing system (dispenser) for test elements112 in the form of test strips. An electronic evaluation device is notprovided in this example.

The portable measuring system 110 in FIG. 1 has a housing 114 which, inthis example, is not necessarily designed to be moisture-proof. Instead,the test elements 112 are stored in a moisture-proof primary packaging116. Moreover, a desiccant 118 is also accommodated in this primarypackaging 116. Such desiccants are known to persons skilled in the art.For example, these desiccants can be silica gel, a molecular sieveand/or other chemicals that absorb air moisture.

To use the portable measuring system according to FIG. 1, the primarypackaging 116 is inserted into the housing 114. A test element 112 canbe dispensed through a dispensing opening 117 of the primary packaging116 and through an opening 120 of the housing 114 by means of adispensing mechanism (not shown here). To prevent air moisture frompenetrating into the primary packaging 116 during this dispensingprocedure, an individual seal (for example a sealing film) of the testelement 112 can be punctured during the dispensing procedure. Otherconfigurations are also known, for example closable dispensing slits orthe like in the area of the dispensing opening 117.

A disadvantage of the known portable measuring system 110 according toFIG. 1 is, as has been explained above, the assembly space needed forthe dual packaging of the test elements 112.

In contrast to the device according to FIG. 1, a first illustrativeembodiment of a portable measuring system 210 according to the inventionis shown in FIG. 2. In this illustrative embodiment, it is assumed thatthe portable measuring system 210 is used to determine blood glucoseconcentrations. As has been explained above, however, other possibleuses are also conceivable. For this purpose, the portable measuringsystem 210 in this example has a moisture-proof housing 212, whichencloses an internal atmosphere 214 of the housing.

The “internal atmosphere of the housing” designates the cavity enclosedby the moisture-proof housing 212 and at the same time also theatmosphere, that is to say the properties of the gas (generally air) inthe cavity. In the simplified depiction according to FIG. 2, themoisture-proof housing 212 has a single cavity, although otherconfigurations are also conceivable. For example, it is not absolutelynecessary for the whole of the moisture-proof housing to bemoisture-proof as such. All that is required is that the moisture-proofhousing 212 encloses in a moisture-proof manner the area in which testelements 112 are received (internal atmosphere 214 of the housing).

“Moisture-proof” is understood here not only as protection againstsplash water or rain, but also protection against water vapor and airmoisture. Complete watertightness can also be provided. It should benoted, however, that one hundred percent protection against air moistureis in most cases not technically feasible, with the result that“moisture-proof” or “substantially moisture-proof” is also to beunderstood as meaning that penetration of air moisture is merelydelayed. The moisture penetrating through the walls of the housing 114as a result of diffusion is bound by the desiccant 118. For example,with penetration of 1 mg of air moisture per day, a supply of desiccant118 of 1 g with 10% by weight binding capacity ensures a storage periodof about 100 days.

The portable measuring system according to the illustrative embodimentin FIG. 1 is based on measurement by means of test elements 112, whichcan be designed according to the prior art. For example, these can beelectrochemical test strips, for example, capillary-gap test elementsand/or optical test strips.

The test elements 112 are held on a test element support 216 which canbe inserted into the internal atmosphere 214 of the housing and which inturn has a retaining structure 218. This retaining structure 218 can, asin FIG. 2, be designed in the form of a drum, for example, on which thetest elements 112 are received peripherally in radial longitudinalslits. In contrast to FIG. 1, a primary packaging 116 is not used, whichmeans that the test elements 112 are exposed directly to the internalatmosphere 214 of the housing. The substantially moisture-proof housing212 thus replaces the primary packaging 116 and so takes over thefunctions of the elements 114 and 116 according to FIG. 1.

The test element support 216 can be removed from the moisture-proofhousing 212 via an insertion opening 220, closable in a moisture-proofmanner (for example a lockable flap sealed off by an O-ring), and can bereplaced by a test element support 216 which is equipped with unusedtest elements 112 and which, for this purpose, is taken from a blisterpack, for example. When inserted, the test element support 216 engagesin a receiving seat 222, in which it is mounted so as to rotate by meansof a drive 224.

A desiccant 118 is also received in the internal atmosphere of thehousing. Alternatively, or in addition, a desiccant 118 can be receivedon and/or in the test element support 216 such that this desiccant 118is also renewed each time a test element support 216 is replaced.

In this example, the drive 224 acts as a release mechanism 228, by meansof which a test element 112 to be used is conveyed into an applicationposition 230. In this application position 230, a liquid sample can beapplied to the test element 112 in the moisture-proof housing 212 via anapplication opening 232. For this purpose, the application opening 232has a sealing element 234. In this illustrative embodiment, this sealingelement 234 according to FIG. 2 is designed as a sealing slide which canbe pushed aside, for example by a patient's finger, such that theapplication opening 232 is freed. A blood droplet present on the fingercan then be applied to the test element 112 to be used in theapplication position 230. For this purpose, the test element 112 to beused can also be pushed by a mechanism (not shown here) nearer to theapplication opening 232.

In the illustrative embodiment according to FIG. 2, it is assumed hereinbelow that the test elements 112 are electrochemical test elements, forexample, test elements in the form of capillary gap test elements.Accordingly, an electronic evaluation device 226 is provided whichelectrically contacts the test element 112 located in the applicationposition 230 and generates a corresponding measured value. For thispurpose, the electronic evaluation device 226 can comprise, for example,a microcomputer, evaluation electronics, operating elements (e.g.,pushbuttons, switches, keys, etc.), acoustic and/or optical outputelements (e.g. one or more displays), data memories and other elements.Electronic evaluation devices 226 of this kind are known from the priorart. The electronic evaluation device 226 can, for example, also controlthe release mechanism 228.

Moreover, in the illustrative embodiment according to FIG. 2, a moisturesensor 236 (it can alternatively or additionally be a temperaturesensor) and a warning system 238 are provided in the internal atmosphere214 of the housing. For example, the warning system 238 can be acomponent part of the electronic evaluation device 226. The warningsystem can be designed, for example, in such a way that it emits anacoustic and/or optical warning to a user as soon as the air moisture inthe internal atmosphere 214 of the housing exceeds a predeterminedthreshold value. As has been described above, another mode of operationis also conceivable, for example, an integration of the air moistureover time. This can also be done taking into account a measuredtemperature in the internal atmosphere 214 of the housing.

The moisture-proof housing 214 is designed, for example, as a one-partor multi-part injection molded component. Methods for makinginjection-molded housings of this kind moisture-proof are known topersons skilled in the art. For this purpose, suitable plastics with lowpermeability for air moisture and oxygen and/or suitable sealing devices(e.g. sealing rings) can be used, for example. Accordingly, the sealingelement 234 can also be configured in various ways. As has beendescribed above, one or more sealing lips can be used as an alternativeto or in addition to the spring-mounted sealing slide shown in FIG. 2.Such sealing elements can be produced, for example, by means ofmulti-component injection molding and/or by encapsulation of suitablesealing elements (for example, rubber lips) in a suitable injectionmolding tool. The sealing element or sealing elements can be opened(alternatively or cumulatively) either by the patient (e.g., via manualslides, etc.) or automatically by a dedicated drive mechanism.

Moreover, the moisture-proof housing 212 in the illustrative embodimentaccording to FIG. 2 has a pressure-equalizing structure 240. In thisillustrative embodiment, this pressure-equalizing structure 240 isdesigned as a pressure-equalizing membrane 242 which is integrated intothe moisture-proof housing 212 (again by encapsulation, for example).This pressure-equalizing membrane 242 prevents penetration of airmoisture into the internal atmosphere 214 of the housing and permitspressure equalization between the internal atmosphere 214 of the housingand the external atmosphere 244. This prevents “breathing” of theportable measuring system 210 during which, for example as a result oftemperature fluctuations, air exchange could take place through theapplication opening 232.

The moisture-proof housing 212 as a whole can be designed in such a waythat air moisture is kept away from the internal atmosphere 214 of thehousing. The moisture-proof housing 212 can also provide protectionagainst entry of splash water or even ensure that the whole portablemeasuring system 210 is waterproof. This also allows the portablemeasuring system 210 to be cleaned with aggressive cleaning agents. Themoisture introduced into the internal atmosphere 214 of the housing byapplication of the liquid sample via the application opening 232 cangenerally be absorbed without any problem by the desiccant 118.

Instead of the test element support 216 with the drum-shaped retainingstructure 218 shown by way of example in FIG. 2, other structures canalso be easily used, for example, arrangements in the form of stacks,disks, rows and or zigzags. FIGS. 2 and 3 show a further example inwhich the test element support 216 is designed with a circular diskshape in the form of a test strip wheel.

The portable measuring system 210 according to the illustrativeembodiment in FIGS. 2 and 3 also contains an integrated lancet system310 in the form of a multi-tipped lancet wheel mounted so as to berotated by a drive 312.

During operation, a lancet 314 to be used is first rotated to a kinkingstation 316. In this kinking station 316, the lancet 314 to be used iskinked upward by 90° (in FIG. 3) by means of a spring mechanism 318.Thereafter, the lancet wheel is rotated through 180° by means of thedrive 312, until the upwardly kinked lancet is below the applicationopening 232 in the housing 212. In this illustrative embodiment, theapplication opening 232 is designed as a cone and is again closed by asealing element 234. The sealing element 234 can be pushed aside by thefinger 320 of the patient, thus exposing the application opening 232. Atthe same time, the finger 320 closes this application opening 232. Bypressing the finger 320 onto the application opening 232, the skin ofthe finger 320 in the area of the application opening 232 forms a bulgecurving into the interior of the housing 212. When the portablemeasuring system 210 is triggered, a lancet spring mechanism 322 ensuresthat the lancet 314, which is located below the application opening 232and is bent upward, is accelerated and perforates the skin of the finger320 within the application opening 232. A blood droplet 324 is thusformed.

The test element support 216 designed in this illustrative embodimentaccording to FIGS. 3 and 4 as a circular disk is divided into circulardisk sectors 326. Each of these circular disk sectors 326 forms a testelement 112. Each of these test elements 112 has a reagent layer 328which, as has been described above, reacts to the presence and/orconcentration of the analyte in the liquid sample (blood droplet 324).In this illustrative embodiment according to FIGS. 3 and 4, this reagentlayer 328 is, for example, a reagent layer 328 for a color reaction inthe presence of glucose, i.e., a reagent layer 328 which, by reactionwith glucose, changes its color and/or its fluorescence properties.

After the skin in the area of the application opening 232 has beenperforated, a test element spring mechanism 330 briefly bends the testelement support 216 upward in the area of the application position belowthe application opening 232, even as far as the application opening 232.In this way, the blood droplet 324 is applied to the reagent layer 328of the test element 112 located in the application position 230, and thedescribed reaction can take place.

The release mechanism 228 then turns the test element support 216through 180° such that the test element 112 on which the blood droplet324 has been applied is placed above or below an optical reader 332.This optical reader 332 carries out a simple optical measurement, forexample, or a measurement of fluorescence excitation. The optical reader332 is connected to the electronic evaluation device 226, which can bedesigned analogously to FIG. 2 and can, for example, comprise amicroprocessor, operating elements, displays, data memories or the like.

The fully integrated portable measuring system 210 according to theillustrative embodiment in FIGS. 3 and 4 shows particularly clearly theadvantages of these teachings. That is, the reagent layer 328 is exposeddirectly to the internal atmosphere 214 of the housing. A separatesealing of the individual test elements 112 is neither necessary nordesirable. If a seal first had to be removed from the individual reagentlayers 328, this would require additional mechanical outlay, which inturn would be disadvantageous in terms of the energy requirement and theassembly space, since further mechanical devices and actuating elementswould be needed. Once again, for example, a desiccant 118 (not shown inFIG. 3 or FIG. 4) can be integrated in the test element support 216designed here in the form of a circular disk.

While exemplary embodiments incorporating the principles of the presentinvention have been disclosed hereinabove, the present invention is notlimited to the disclosed embodiments. Instead, this application isintended to cover any variations, uses, or adaptations of the inventionusing its general principles. Further, this application is intended tocover such departures from the present disclosure as come within knownor customary practice in the art to which this invention pertains andwhich fall within the limits of the appended claims.

LIST OF REFERENCE NUMBERS

-   110 portable measuring system (prior art)-   112 test element-   114 housing-   116 primary packaging-   117 dispensing opening-   118 desiccant-   120 opening-   210 portable measuring system-   212 moisture-proof housing-   214 internal atmosphere of housing-   216 test element support-   218 retaining structure-   220 insertion opening-   222 receiving seat-   224 drive-   226 electronic evaluation device-   228 release mechanism-   230 application position-   232 application opening-   234 sealing element-   236 moisture sensor-   238 warning system-   240 pressure-equalizing structure-   242 pressure-equalizing membrane-   244 external atmosphere-   310 integrated lancet system-   312 drive-   314 lancet-   316 kinking station-   318 spring mechanism-   320 finger-   322 spring mechanism for lancets-   324 blood droplet-   326 sectors of circular disk-   328 reagent layer-   330 spring mechanism for test element-   332 optical reader

1.-23. (canceled)
 24. A portable measuring system used for analyzing aliquid sample for at least one analyte contained therein, the measuringsystem comprising a plurality of test elements within a single internalatmosphere contained by a substantially moisture-proof housing, thehousing having a single resealable opening for the application of testfluid.
 25. The portable measuring system of claim 24, further comprisinga sealing element disposed proximate the application opening.
 26. Theportable measuring system of claim 25, wherein the sealing elementcomprises a sealing lip, a sealing ring, a sealing slide, an applicationflap, a movable sealing element, or a two-component plastic structurewith at least one rigid and at least one flexible housing component. 27.The portable measuring system of claim 24, further comprising a releasemechanism configured to convey the test elements into an applicationposition within the internal atmosphere, wherein test elementspositioned in the application position are accessible to the liquidsample.
 28. The portable measuring system of claim 24, furthercomprising a desiccant in the internal atmosphere of the housing. 29.The portable measuring system of claim 24, further comprising apressure-equalizer for substantially preventing penetration of moisturewhen a pressure of the internal atmosphere changes relative to the airpressure outside the internal atmosphere.
 30. The portable measuringsystem of claim 24, further comprising a flexible volume-modifyingelement.
 31. The portable measuring system of claim 30, wherein theflexible volume-modifying element comprises a pressure-equalizingmembrane.
 32. The portable measuring system of claim 24, furthercomprising a moisture sensor or temperature sensor for measuring themoisture or temperature of the internal atmosphere.
 33. The portablemeasuring system of claim 32, further comprising a warning system foremitting a warning to a user if at least one of the following valuesexceeds one or more predefined threshold values: the moisture of theinternal atmosphere; the temperature of the internal atmosphere of thehousing.
 34. The portable measuring system of claim 33, furthercomprising a climate integrator that takes account of time, moisture andtemperature.
 35. The portable measuring system of claim 24, wherein theretaining structure has a retaining rotor or drum that is rotatable inthe housing.
 36. The portable measuring system of claim 24, furthercomprising a desiccant.
 37. The portable measuring system of claim 24,further comprising an electronic evaluation device for determining thepresence or the concentration of the at least one analyte.
 38. Theportable measuring system of claim 24, further comprising an integratedlancet system for perforating an area of skin.
 39. The portablemeasuring system of claim 38, wherein the integrated lancet system isreceived in the housing.
 40. The portable measuring system of claim 38,wherein the integrated lancet system has a plurality of disposablelancets.
 41. The portable measuring system of claim 24, wherein the testelements have a reagent layer which changes at least one propertythereof upon contact with the analyte to be detected, further wherein,when a test element support is inserted into the internal atmosphere,the reagent layer of each test element is exposed to the internalatmosphere.
 42. The portable measuring system of claim 24, furthercomprising a test element support that is insertable into the internalatmosphere, the test element support having a retaining structuresupporting the plurality of test elements, the test element supportconfigured such that, after insertion into the internal atmosphere, thetest elements are all exposed to the single internal atmosphere.
 43. Aportable measuring system used for analyzing a liquid sample for atleast one analyte contained therein, comprising: a substantiallymoisture-proof housing having an internal atmosphere, the housingsubstantially preventing moisture from penetrating into the internalatmosphere; a test element support that is insertable into the internalatmosphere, the test element support having a retaining structure and aplurality of test elements supported by the retaining structure, thetest element support configured such that, after insertion into theinternal atmosphere, the test elements are all exposed to the sameinternal atmosphere; an application opening through which liquid sampleis applied to a test element defined in the housing and having a sealingelement disposed proximate the application opening; and wherein, theliquid sample is applied through the application opening to the testelements within the internal atmosphere and the sealing element sealsthe application opening before and after the application of liquidsample.
 44. The portable measuring system of claim 43 wherein thesealing element comprises a sealing lip, a sealing ring, a sealingslide, an application flap, a movable sealing element, or atwo-component plastic structure with at least one rigid and at least oneflexible housing component.
 45. The portable measuring system of claim43, further comprising a release mechanism configured to convey the testelements into an application position within the internal atmosphere,wherein test elements positioned in the application position areaccessible to the liquid sample.
 46. The portable measuring system ofclaim 43, further comprising a desiccant in the internal atmosphere ofthe housing.
 47. The portable measuring system of claim 43, furthercomprising a pressure-equalizer for substantially preventing penetrationof moisture when a pressure of the internal atmosphere changes relativeto the air pressure outside the internal atmosphere.
 48. The portablemeasuring system of claim 43, further comprising a flexiblevolume-modifying element.
 49. The portable measuring system of claim 48,wherein the flexible volume-modifying element comprises apressure-equalizing membrane.
 50. The portable measuring system of claim43, further comprising a moisture sensor or temperature sensor formeasuring the moisture or temperature of the internal atmosphere. 51.The portable measuring system of claim 50, further comprising a warningsystem for emitting a warning to a user if at least one of the followingvalues exceeds one or more predefined threshold values: the moisture ofthe internal atmosphere; the temperature of the internal atmosphere ofthe housing.
 52. The portable measuring system of claim 51, furthercomprising a climate integrator that takes account of time, moisture andtemperature.
 53. The portable measuring system of claim 43, wherein theretaining structure has a retaining rotor or drum that is rotatable inthe housing.
 54. The portable measuring system of claim 43, furthercomprising a desiccant connected to the test element support.
 55. Theportable measuring system of claim 43, further comprising an electronicevaluation device for determining the presence or the concentration ofthe at least one analyte.
 56. The portable measuring system of claim 43,further comprising an integrated lancet system for perforating an areaof skin.
 57. The portable measuring system of claim 56, wherein theintegrated lancet system is received in the housing.
 58. The portablemeasuring system of claim 56, wherein the integrated lancet system has aplurality of disposable lancets.
 59. The portable measuring system ofclaim 43, wherein the test elements have a reagent layer which changesat least one property thereof upon contact with the analyte to bedetected, further wherein, when the test element support is insertedinto the internal atmosphere, the reagent layer of each test element isexposed to the internal atmosphere.